Novartis announced January 15 that the FDA approved Cosentyx (secukinumab) for psoriatic arthritis and active ankylosing spondylitis.
Novartis announced January 15 that the FDA approved Cosentyx (secukinumab) for psoriatic arthritis and active ankylosing spondylitis. The announcement comes a year after the FDA’s approval for Cosentyx for treatment of adults with moderate to severe psoriasis. The drug is the only IL-17A antagonist approved for all three indications.
“Cosentyx is an outstanding treatment for patients with moderate-to-severe psoriasis; this new FDA approval now allows dermatologists and rheumatologists to treat their psoriasis patients with joint pain and inflammation with this same medication,” Andrew Blauvelt, M.D., M.B.A., president of the Oregon Medical Research Center, Portland, Ore., told Dermatology Times. Dr. Blauvelt is a consultant and Cosentyx clinical trial investigator for the psoriasis program at Novartis Pharmaceuticals Corporation.
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The biologic was more effective than placebo in a phase 3 study of 606 adults with psoriatic arthritis. Researchers of the study, published October 2015 in the New England Journal of Medicine, randomly assigned subjects to receive intravenous secukinumab (at a dose of 10 mg per kilogram) at zero, two and four weeks, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every four weeks, or placebo.
American College of Rheumatology 20 (ACR20) response rates at week 24 were 50 percent in the group receiving secukinumab at doses of 150 mg; 50.5 percent in the75 mg secukinumab group; and 17.3 percent in the placebo group. Those on the active drug also had significantly less joint structural damage than subjects on placebo.
Candida and other infections were more common in the secukinumab groups.
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“Throughout the study (mean secukinumab exposure, 438.5 days; mean placebo exposure, 128.5 days), four patients in the secukinumab groups had a stroke … and two had a myocardial infarction …, as compared with no patients in the placebo group,” according to the study’s abstract. “The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use.”
In another study, funded by Novartis, published September 2015 in The Lancet, researchers reported on a phase 3 double-blind, placebo-controlled study of patients with psoriatic arthritis at 76 centers around the world. In the study of nearly 400 adults, they found subcutaneous secukinumab 300 mg and 150 mg improved the signs and symptoms of psoriatic arthritis.
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The FDA’s approvals for both psoriatic arthritis and active ankylosing spondylitis were based on the outcomes of four phase 3 studies, including more than 1,500 patients.